Overview

Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.

Status:
Completed

Trial end date:
2008-12-01

Target enrollment:
0

Participant gender:
All

Summary

In this study we will investigate whether tranexamic acid given as an intravenous bolus injection before start of surgery, followed by a continuous infusion during surgery reduces, perioperative hemostatic activation, and postoperative bleeding and the need for transfusions of blood components in elderly patients undergoing combined aortic valve replacement and coronary artery bypass surgery. Tranexamic acid will be compared with placebo (0.9% sodium chloride) in a randomized and double-blind study design. The study hypothesis is that tranexamic acid will reduce hemostatic activation and postoperative hemorrhage and the need for blood component transfusions in this group of patients.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

St. Olavs Hospital

Treatments:

Tranexamic Acid

Criteria

Inclusion Criteria: Patients above 70 years of age scheduled for combined aortic valve
replacement and coronary artery bypass surgery.

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Exclusion Criteria: Patients younger than 70 years of age. Patients scheduled for other
procedures than combined aortic valve replacement and coronary artery bypass surgery.
Patients who are not treated with aspirin. Patients with a medical condition known to
influence the hemostatic system. Patients treated with drugs other than aspirin during the
last week before surgery that may influence the hemostatic system, such as warfarin
(coumarin), non-steroidal antiinflammatory drugs, clopidogrel, heparin, low molecular
heparins. Patients who are treated with systemic steroids. Patients with a serum creatinin
concentration above 140 micromol/l. Patients with an INR above 1.5. Patients who are not
able to give written informed concent.

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